The effect of remimazolam-based total intravenous anesthesia versus sevoflurane-based inhalation anesthesia on emergence delirium in children undergoing tonsillectomy and adenoidectomy: study protocol for a prospective randomized controlled trial

Autor: Hong-Yu Ma, Yu-Hang Cai, John Wei Zhong, Jia Chen, Zhen Wang, Chao-Yi Lin, Qiao-Qiao Wang, Hua-Cheng Liu
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Frontiers in Pharmacology, Vol 15 (2024)
Druh dokumentu: article
ISSN: 1663-9812
DOI: 10.3389/fphar.2024.1373006
Popis: Background: Remimazolam, a new ultrashort-acting benzodiazepine, is becoming increasingly applied in general anesthesia. This study is designed to investigate the effect of remimazolam-based total intravenous anesthesia and sevoflurane-based inhalation anesthesia on emergence delirium in pediatric tonsillectomy and adenoidectomy.Methods and analysis: This is a monocentric, prospective, randomized, double-blind clinical trial. A total of 90 pediatric patients will be randomized to receive remimazolam-based total intravenous anesthesia (remimazolam group, n = 45) or sevoflurane-based inhalation anesthesia (sevoflurane group, n = 45). The primary outcome will be the incidence of emergence delirium, which will be evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The secondary outcomes include the extubation time, recovery time, behavior change using the post-hospitalization behavior questionnaire for ambulatory surgery (PHBQ-AS), and adverse events.Ethics and dissemination: This study has been approved by the Institutional Review Board (IRB) of the Second Affiliated Hospital and Yuying Children’s Hospital of Wenzhou Medical University (2023-K-262-02).Clinical trial registration:ClinicalTrials.gov, identifier NCT06214117.
Databáze: Directory of Open Access Journals